5种中药制剂微生物限度检查方法验证

目的：通过微生物限度检查,建立5种中药制剂的微生物限度检查方法。方法：参考《中国药典》等文献进行试验,并对所采用的方法进行方法学验证。结果：根据回收率试验结果,扶肾颗粒、黄地散颗粒、糖毒清颗粒3种供试品各试验菌的回收率均高于70%,证明无抑菌现象;软坚止痛膏有一定程度的抑菌作用,可通过培养基稀释法消除抑菌作用;而舒筋搽洗液抑菌作用强,采用薄膜过滤法才能彻底消除其抑菌作用。结论：扶肾颗粒、黄地散颗粒、糖毒清颗粒按常规法进行微生物限度检查,软坚止痛膏按培养基稀释法进行微生物限度检查,舒筋搽洗液按薄膜过滤法进行微生物限度检查。

Validation of microbial limit test for five Traditional Chinese Medicines

Objective：To establish a method to determine the microbial limit viable count tests for five Medicines.Method Counting alive microbal test and vilidation methods were conducted according to the Chinese pharmacopoeia and other literature.Results： The recovery rates of Fushen Granule,Huangdisan Granule and Tangduqing granule were higher than 70%,which indicated no antimicrobial effects.Ruanjianzhitong unguent had antimicrobial effects to some extent,which could be blocked by dilution.Shujin chaxi Liquid had higher antimicrobial effects,which could be eliminated by membrane filtration.Conclusions： The results suggest that the routine method be used for Fushen Granule,Huangdisan Granule,Tangduqing Granule.Medium dilution method can be applied to Ruanjianzhitong unguent.For Shujin chaxi Liquid,the membrane filtration method should be used.